Automated therapy system and method

ABSTRACT

An automated therapy system having an infusion catheter; a sensor adapted to sense a patient parameter; and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. The invention also includes a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/937,102, filed Jul. 8 2013; which application is a continuation ofU.S. application Ser. No. 13/354,210, filed Jan. 19, 2012, now U.S. PatNo. 8,480,648; which application is a continuation of U.S. applicationSer. No. 12/098,365, filed Apr. 4, 2008, now U.S. Pat. No. 8,100,880;which application claims the benefit of U.S. Provisional PatentApplication No. 60/921,974, filed Apr. 5, 2007 to Burnett, entitled“Safety Access Device, Fluid Output Monitor & Peritoneal OrganPreservation”, all disclosures of which are incorporated by referenceherein in their entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND OF THE INVENTION

Fluids and other substances are infused into patients for a variety ofreasons. For example, fluids may be given to a patient intravenously tohydrate the patient or to control overall blood volume.

It is often important to control infusion of fluid into patients inorder to optimize the therapy being provided. Monitoring of patientparameters can consume precious health care time and resources, however.Fluid infusion into patients is therefore not always optimized.

Mantle US 2006/0161107 describes a system that extracts fluid from abody cavity, processes the fluid and then recirculates fluid back intothe cavity. Mantle does not describe infusion of a fluid into a patientwithout extraction of the fluid from the patient, however. In addition,the parameters on which the Mantle system is controlled are limited.

SUMMARY OF THE INVENTION

One aspect of the invention provides an automated therapy system havingan infusion catheter; a sensor adapted to sense a patient parameter; anda controller communicating, with the sensor and programmed to controlflow output from the infusion catheter into a patient based on thepatient parameter without removing fluid from the patient. In someembodiments, the sensor may be incorporated into the catheter, and inother embodiments, the sensor may be separate from the catheter. Thesensor may be, e.g., an ECG sensor; an EEG sensor; a pulse oximetrysensor; a blood pressure sensor; a cardiac output sensor; athermodilution cardiac output sensor; a cardiac stroke volume sensor; aheart rate sensor; a blood flow sensor; a pH sensor; a blood pO₂ sensor;an intracranial pressure sensor; and/or a solute sensor.

In embodiments of the invention, the catheter may be a peripheral venouscatheter; a central venous catheter; an arterial catheter; or aperitoneal catheter (possibly incorporating an intraperitoneal pressuresensor).

Another aspect of the invention provides a method of controllinginfusion of a fluid to a patient. The method includes the followingsteps: monitoring a patient parameter with a sensor to generate a sensorsignal; providing the sensor signal to a controller; and adjusting fluidflow to the patient based on the sensor signal without removing fluidfrom the patient. In some embodiments, the method includes the step ofmonitoring cardiac output with the sensor and, possibly, adjusting fluidflow to the patient based on cardiac output monitored by the sensor. Inembodiments of the invention, the patient parameter includes anelectrocardiogram; an electroencephalogram; blood oxygen saturation;blood pressure; cardiac. output; cardiac stroke volume; heart rate;blood flow; total circulating blood volume; whole body oxygenconsumption; pH; blood pO₂; osmolarity; peritoneal cavity compliance;intrathoracic pressure; bladder pressure; and/or rectal pressure.

In some embodiments, the adjusting step includes the step of adjustingfluid flow to achieve or maintain patient euvolumia; adjusting flow of atherapeutic agent (such as a chilled medium) to the patient; adjustingfluid flow to the patient through a peripheral venous catheter;adjusting fluid flow to the patient through a central venous catheter;adjusting fluid flow to the patient through an arterial catheter; and/oradjusting fluid flow to the patient's peritoneal cavity.

Yet another aspect of the invention provides a method of treatinghypotension in a patient. The method includes the following steps:monitoring a patient parameter (such as blood pressure or cardiacoutput) with a sensor to generate a sensor signal; providing the sensorsignal to a controller; and adjusting fluid flow to the patient based onthe sensor signal without removing fluid from the patient.

Still another aspect of the invention provides a method of treatingsepsis in a patient. The method includes the following steps: monitoringa patient parameter (such as blood pressure, central venous pressure, orcardiac output) with a sensor to generate a sensor signal; providing thesensor signal to a controller; and adjusting fluid flow to the patientbased on the sensor signal without removing fluid from the patient.Prevention of hypotension and/or hypovolemia is critical in the care ofpatients that have suffered severe hemorrhage or are septic. Thesepatients are very difficult to monitor and treat, taking significantnursing time and still resulting in suboptimal therapy due to theintermittent nature of the blood pressure, central venous pressureand/or cardiac output cheeks. The present invention, then, will optimizefluid flow to the patient while also freeing up the already over-taxednursing staff for other duties.

Yet another aspect of the invention provides a method of inducing andreversing therapeutic hypothermia in a patient. The method includes thesteps of: monitoring intracranial pressure to generate a sensor signal;providing the sensor signal to a controller; and adjusting rate ofhypothermia induction or rewarming based on intracranial pressure (suchas by adjusting fluid flow to the patient), or depth of hypothermia,based on the sensor signal.

In some embodiments of the invention, irrigation and/or lavage of bodilytissues, cavities or spaces (or other patient interventions) may beoptimized using a sensor or sensors to report electrical, chemical,acoustic, mechanical properties, pressure, temperature, pH or otherparameters surrounding the access device in order to automate andoptimize the irrigation/lavage.

Embodiments of the invention include a peritoneal catheter containingone or more sensors which may detect changes in electrocardiographmonitoring, electroencephalograph monitoring, pulse oximetry (eitherinternally or peripherally), peritoneal cavity compliance, intrathoracicpressure, intraperitoneal pressure, intraperitoneal pressure waveforms,bladder pressure, rectal pressure, cardiac output, cardiac strokevolume, cardiac rate, blood flow (e.g., in superior mesenteric, celiac,renal or other arteries), pressure in veins (particularly the inferiorvena cava or those that empty into the inferior vena cava, e.g., femoralvein), pressure in arteries (particularly those distal to the aorta,e.g., the femoral artery), total circulating blood volume, bloodoxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.),whole body oxygen consumption, pH and/or arterial pO₂ (or any otherparameter that shows a measurable change with increased peritonealpressure) to ensure safety of automated or manual peritoneal lavage. Theinvention also includes methods of performing peritoneal lavage usingsuch devices.

Embodiments of the invention include an intravascular cathetercontaining one or more sensors which may detect changes inelectrocardiograph monitoring, electroencephalograph monitoring, pulseoximetry (either internally or peripherally), partial pressure of oxygenor CO₂, pH, temperature, blood pressure, central venous pressure,cardiac output, cardiac stroke volume, cardiac rate, blood flow (e.g.,in superior mesenteric, celiac, renal or other arteries), totalcirculating blood volume, pressure in veins (particularly those thatempty into the inferior vena cava, e.g., femoral vein), pressure inarteries (particularly those distal to the aorta, e.g., the femoralartery), blood oxygenation (e.g., in rectal mucosa, peripheral fingersand toes, etc.), whole body oxygen consumption, pH and/or arterial pO₂(or any other parameter that shows a measurable change withintravascular volume overload) to ensure safety of manual or automatedintravascular infusion. The invention also includes methods of usingsuch devices.

Other embodiments of the invention include control of the rate ofinfusion to minimize negative effects observed by the sensors. Theinvention may be used to induce and/or maintain hypothermia orhyperthermia; maximize hydration and/or intravascular volume in apatient receiving intravenous fluids (such as, e.g., post-operativepatients, post-hemorrhage patients, septic patients or other intensivecare patients),

Disclosed is a method and device for detection of intake and/or outputin an individual. Fluid detection may be fully automated and the usermay be alerted if volumes become too low or too high. The data may alsobe automatically routed to a centralized data collection server so thatit may be collected and accessed without the requirement for nursing orother healthcare personnel to record the information manually. Theoutput receptacle, in particular, may contain wireless technology, ieRFID, as well to optimize data collection and reduce nursing burden.

In reviewing the obstacles of urine output monitoring and datacollection, then, it becomes clear that what is needed for widespreadadoption is an easily implemented system capable of accurately measuringurine output wherein the use of the device reduces the nursing burdenwhile reporting any issues with urine output in a timely manner. Thepresent invention may also measure and report bladder temperature inreal-time and this information may be used to alert the healthcareproviders of changes in therapy and/or may be used to control and directdepth of therapeutic hypothermia. The reservoir/receptacle may alsocontain sensors capable of detecting other materials of interest withinthe fluid including, but not limited to: hemoglobin, blood, bacteria,leukocyte esterase, glucose, protein, particulate matter, etc. Thisinformation may also trigger an alert to provide real-time datamonitoring of these parameters. Additionally, the present inventionanticipates the use of wired or, ideally, wireless transmission of datato allow for centralized collection of data and centralized reporting.This is, once again, useful in reducing healthcare provider burden byallowing fewer personnel to monitor the data from all of the patientsutilizing said system.

In addition, the system of the present invention anticipates the use ofRFID technology within or attached to the reservoir itself which may beremotely queried and interrogated by one or more RFID readers. The datacollected may be encrypted and specific to each receptacle such that theup.ne output reported may be securely associated with an individualpatient. In its optimal embodiment, the reservoir may contain conductingchannels connected to the RFID circuitry which determine the urine levelby detection of the level of a simple short-circuit through theconducting fluid itself which may then be reported by the RFID chip tothe reader. This cheap, easy-to-use system overcomes the obstacles ofprevious attempts to automate urine output monitoring.

In addition, information collected using the present invention may beused to automatically adjust therapeutic hypothermia, delivery ofmedicine or other interventions.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 shows an automated infusion system in which infusion iscontrolled based on patient parameters sensed by multiple sensors.

FIG. 2 shows an automated infusion system in which a sensor controllinginfusion is separate from the infusion catheter.

FIG. 3 shows an automated infusion system in which sensing and infusionare performed with the same catheter.

FIG. 4—Console with optional sensor lead (may be wireless).

FIG. 5—Sensor-based Urine Output Measurement.

FIG. 6—Console with automated infusion therapy system.

FIG. 7—Volume-sensing Urine Receptacle with Dock.

FIG. 8—Volume-sensing Urine Receptacle—RFID Embodiment

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1-3 show embodiments of the invention wherein intravenous fluiddelivery may be automated, or manually adjusted, based on feedback fromone or more sensors. In these embodiments, the infusion catheter mayhave a sensor to aid in insertion, but this is not necessary for thisinvention.

In one embodiment, the infusion catheter also is used to detect theparameters used to optimize therapy. FIG. 1 shows an infusion systemwith an infusion controller 10 operably connected to an intravenousinfusion catheter 12 via an infusion line 14. Infusion catheter 12 alsohas a sensor (not shown) attached to or associated with it to monitor apatient parameter. The sensor also communicates with controller 10either through line 14 or via some other communication channel. Suitablepatient parameters include electrocardiograph monitoring,electroencephalograph monitoring, pulse oximetry (either internally orperipherally), blood pressure, central venous pressure, cardiac output,cardiac stroke volume, cardiac rate, blood flow (e.g., in superiormesenteric, celiac, renal or other arteries), total circulating bloodvolume, pressure in veins (particularly those that empty into theinferior vena cava, e.g., femoral vein), pressure in arteries(particularly those distal to the aorta, e.g., the femoral artery),blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes,etc.), whole body oxygen consumption, pH, arterial pO₂, or any otherparameter that shows a measurable change with intravascular volumeoverload.

As shown in FIG. 1, additional catheters, here envisioned as aperipherally inserted central catheter (PICC) 16 and/or a peritonealcatheter 18, or additional sensors on infusion catheter 12 may be usedto monitor these or other parameters, and to optimize the infusion rateand achieve euvolemia without fluid overload or dehydration. Flow offluid and/or a fluid/solid mixture an ice slurry) to catheters 16 and/or18 is controlled by controller 10 through lines 14, 15 and/or 17,respectively. The information from the sensors may then be transmittedto central controller 10, which integrates all of this information todetermine the flow of intravenous fluid through catheter 12 and/orcatheter 16 and flow of peritoneal fluid through catheter 18. Thisinformation may be used to achieve or maintain euvolemia (e.g., insepsis, hemorrhagic shock, etc.) or to maximize infusion for delivery ofa therapeutic, agent, e.g., chilled fluid and/or solids to achievehypothermia. Alternatively, catheters 16 and 18 may be used with sensorsto Obtain patent information, and fluid may be infused into the patientsolely through catheter 16 or catheter 18. In yet further embodiments,the depth of hypothermia and/or rate of hypothermia induction orrewarming may be tailored based on intracranial pressure sensor(s) (notshown) communicating with controller 10 via communication line 35. Thissystem and method may be used with any method of inducing hypothermia(e.g., cooling blankets, intravascular catheters, intravenous fluidinfusion, peritoneal lavage, etc.) so long as the change in temperature,particularly rewarming, is controlled at least in pan by an intracranialpressure sensor,

The sensor or sensors, whether cables/catheters or percutaneousmonitoring technologies, and whether wired or wireless, may also beseparate from the infusion line so long as the information from thissensor or sensors is transferred to the control unit in order tooptimize fluid flow. Thus, as shown in FIG. 2, the patient parametersensor may be associated with PICC 24 and communicate with controllervia line 26, and infusion to the patient may be via line 22 and infusioncatheter 20, as controlled by controller 10. In some embodiments, ofcourse, sensing and infusion may be performed through a single catheter,such as PICC 30, and controlled by controller 10 through lines 32 and34, as shown in FIG. 3. In some embodiments, the infusion and monitoringdevice of the current invention may incorporate an access sensor, suchas that described in a commonly owned patent application, U.S. patentapplication Ser. No. 12/098,355, filed Apr. 4, 2008, titled “Device AndMethod For Safe Access To A Body Cavity”.

One example of such a device is a peripheral venous, central venous orarterial catheter that is capable of maintaining hydration withoutcausing fluid overload. The catheter may incorporate a sensor that maydetect central venous pressure, total circulating blood volume,peripheral venous pressure, cardiac output or osmolarity, and/or soluteconcentrations (e.g., chloride, sodium, etc.) in order to prevent fluidoverload. The sensor may also be external to the catheter, so long asthe output of said sensor is capable of controlling fluid flow throughthe catheter. In this embodiment, fluid flow is controlled by the outputof the sensor, which is integrated by a fluid flow control unit whichalters the rate of fluid flow based on this output. This embodiment mayallow the user to bolus large volumes of fluids or solids into thevascular space in order to rehydrate, induce hypothermia or reversehypothermia, or deliver a therapeutic agent or maintain blood pressurein sepsis.

In addition, this technology may provide a fully automated mechanism tooptimize fluid flow into the vessel without fluid overloading thepatient. Without this automated fluid delivery coupled to hemodynamicparameter monitoring, the patient is in danger of dehydration or fluidoverload from infusion of fluid into any body cavity. This technologymay also be applied to liquid or solid infusion into any body cavity orspace in so long as the fluid flow is automated based on feedback fromsensors within the body (possibly incorporated into the catheter itself)in order to optimize the volume of infusion.

This device and method of automating fluid flow based on hemodynamicsensor-based feedback may also be used to generate intravenoushypothermia. In its current state, IV hypothermia induction is limiteddue to concerns of fluid overload. If the hemodynamic parameters of thepatient can be measured and fluid flow directly or indirectly controlledbased on the output of these measurements, the volume of fluid can bemaximized while ensuring hemodynamic instability. In this embodiment,the sensor may be incorporated within the catheter, and fluid flow intothe vasculature may be tailored based on central venous pressure, totalcirculating, blood volume, peripheral venous pressure, cardiac output orosmolarity, and/or solute concentrations (e.g., chloride, sodium, etc.)in order to prevent fluid overload.

In one embodiment, the fluid infusion catheter also may function as athermodilution cardiac output sensor such that the same fluid that isused to generate hypothermia may also be used to detect cardiac output.This information may then be relayed, either directly or indirectly,back to the fluid infusion controller to increase, decrease or even haltfluid flow based on these parameters. For example, if cardiac output islow and venous pressure or total circulating volume is low, the patienthas a low circulating volume and large volumes of fluid may be safelydelivered. If the cardiac output is normal, fluid may also be safelydelivered, but the cardiac output must be monitored to ensure that itdoes not begin to decrease (an indication of fluid overload). Bloodflow, as detected by, for instance, thermodilution may be determined ina peripheral vessel as well. These data, while relatively useless ontheir own in a clinical setting due to variability in peripheral bloodflow, may provide a baseline flow profile which may be rechecked overtime in order to compare flow within that individual vessel to thebaseline flow. Relatively improved flow may be correlated to improvedcardiac output, while a relative reduction in flow may be correlated tofluid overload.

This same system may be used to infuse normal fluids or hypothermicfluids to sepsis patients or patients requiring intensive maintenance oftheir hemodynamic status. Sepsis patients that are aggressivelymonitored do much better than those that are not. Aggressive monitoringis very nurse-intensive, however. A system that provides automatedoptimal fluid infusion based on sensed parameters to ensure that fluidoverload does not occur and that fluid infusion is not insufficientwould be an improvement over current methods of treating sepsispatients. The devices and methods for automated sensor-based input tocontrol fluid flow to a patient may be applicable to a wide range ofconditions and should not be limited to the narrow scope of theconditions requiring fluid infusion described here.

The logic controller of the present invention may provide improvedsafety by monitoring for any of the deleterious changes expected withexcess fluid flow, e.g., into the peritoneal cavity or vascular space.Examples of monitored parameters that may signal a warning orautomatically result in an adjustment to rate of fluidinfusion/extraction and/or fluid temperature include: electrocardiographmonitoring, electroencephalograph monitoring, pulse oximetry (eitherinternally or peripherally), peritoneal cavity compliance, intrathoracicpressure, intraperitoneal pressure, intraperitoneal pressure waveforms,bladder pressure, rectal pressure, cardiac output, cardiac strokevolume, cardiac rate, total circulating blood volume, blood flow (e.g.,in superior mesenteric, celiac, renal or other arteries), pressure inveins (particularly those that empty into the IVC, e.g., femoral vein),pressure in arteries (particularly those distal to the aorta, e.g., thefemoral artery), blood oxygenation (e.g., in rectal mucosa, peripheralfingers and toes, etc.), whole body oxygen consumption, pH and arterialpO₂ and any other parameter that shows a measurable change once theperitoneal or vascular spaces have been overloaded.

These parameters in particular have been found to change with increasesin peritoneal pressure, with significantly negative impact on eachparameter found at 40 mmHg. Thus, monitoring for these changes inconjunction with a peritoneal infusion catheter of the present inventionwill allow for even greater safety with peritoneal infusion. Theseparameters may be measured a variety of ways and the data transmittedeither wirelessly or via wires to the logic controller in order to alertthe healthcare provider or to automatically adjust the fluidflow/temperature in order to optimize both the flow of the peritonealfluid and patient safety.

FIG. 4 illustrates a console 40 with optional sensor lead 44 which mayor may not be wireless. The console itself may record output/input data42. This data may be held in memory, printed or directly transmitted toa centralized data collection server. Said console may connect to theurine receptacle 46 to determine urine output either via a wire orwirelessly.

FIG. 5 illustrates sensor-based Urine Output Measurement. In thisinstance, the console 50 or RFID reader can trigger alert if urineoutput is too low or too high over a set period of time. May also haveintravenous infusion capabilities to provide input and output data andtailor delivery of fluids and/or medicines (ie diuretics) via anautomated system based on the urine output feedback. The device mayinclude an optional Docking Station 54—ideally reusable, may connect toreceptacle 52 and transmit data to control unit either via wires or,ideally, wirelessly. May also measure urine level via weight, etc.Optional Urine Level Sensors 56 may report level of urine viaconductivity, resistance, impedance, etc. Sensors may also continuouslyor intermittently detect bacteria, hemoglobin or other substances ofinterest in urine. Urinary catheter 58 is also shown.

FIG. 6 illustrates a console 60 with automated infusion therapy system.Console may integrate patient data, ie fluids received, urine outputrecorded, etc. to automate therapy, ie delivery of fluids or LASIX ifthe pt is dehydrated or fluid overloaded respectively. May also triggerlocal alert (ie beeping) and centralized alert (ie system alarm) ifurine output drops too low. The console may also integrate a fluidinfusion or medicine infusion capabilities, ie an IV infusion pump, andmay adjust infusion rates based on this data or data acquired from othersensors in an automated fashion. The console may communicate wirelesslyas well, to these and any other sensors within the body. Infusioncatheter 62 is also shown—may deliver drugs or fluid based on urineoutput and other parameters Urinary catheter 64 is also shown.

FIG. 7 illustrates a volume-sensing Urine Receptacle with reusablecommunicating and/or sensing element. The receptacle 70 itself maydetect urine output based upon level at which sensors are triggered-iehave hash-marks represent electrical contacts and when an electricalpath is made between two contacts, and all contacts below, the level canbe reported at that level. May be electrical, optical, chemical ormechanical sensors. May also contain diffuse or discrete sensing areasthat may detect the presence of absence of certain materials ofinterest, ie hemoglobin, protein, glucose, bacteria, blood, leukocyteesterase, etc. either intermittently or continuously. May report anyand/or all of this information to the console, locally (via beeping,etc.) or centrally via piping data to a central information collectionarea. Alerts triggered if urine output drops below 30 cc/hr inpost-operative setting or any otherwise defined threshold. May also bedisposable and connect to the docking station 72 which may communicatethe data from said, receptacle wirelessly. The docking station may beconnected anywhere on said receptacle, or optionally, not included atall. If a docking station is used, it may detect urine output basedsimply upon weight or pressure applied to base. May contain disposableor, ideally, durable optical, electrical or chemical sensors capable ofsensing glucose, electrolytes, bacteria, hemoglobin, blood, etc. Mayinterface with specifically designed area of the urine receptacle toallow for this measurement-ie an optically clear window for opticalmeasurement of blood, etc. May also fasten onto the urine receptacle inany position so long as it engages the receptacle. This or thereceptacle itself may contain an inductive antenna and/or RFIDcapabilities to allow for wireless querying and reporting of the levelof urine or other fluid collection.

FIG. 8 illustrates a volume-sensing Urine Receptacle 80 with RFIDcapabilities. This embodiment may contain RFID circuitry to collect andtransmit data directly from within the receptacle to a RFID Reader. Whenqueried by the RFID reader may simply detect impedance, resistance,capacitance or any other electrical or nonelectrical property to detectthe urine level and report this back to the reader. Reader may thentrigger alert if urine output is high or low. The RFID chip may becapable of detecting changes in optical, chemical, electrical, acousticor mechanical properties, as well. May be active or passive RFID and maycontain antenna in any position and, ideally, may transmit a uniquesignal to identify the receptacle to the reader and allow multiplereceptacles to be queried at once. The RFID chip may incorporate a smallbattery (to extend its range) in an active RFID embodiment or may bepassive in nature and be powered solely by the transmissions from saidRFID reader. The RFID Reader 82 may query device from a distance towirelessly check the urine output level or may be centralized to queryall receptacles within a unit, floor or hospital and issue an alert ifurine output drops too low (or is too high). May record urine output, aswell, and replace the individual unit consoles illustrated in FIGS. 1-3.The RFID reader may also report data from other sensors within saidsystem, including bladder temperature or presence of certain materialswithin the urine, ie blood, hemoglobin, leukocyte esterase, otherindicators of bacterial infection, protein, glucose, etc.

In another embodiment, a urinary catheter capable of sensing physiologicparameters is envisioned. Additional sensing capabilities may include:blood pressure, oxygen saturation, puke oximetry, heart rate, EKG,capillary fill pressure, etc. In particular, the incorporation of pulseoximetry technology to allow for blood oxygen concentration orsaturation determination with a urinary catheter is envisioned. Thisdevice may function by incorporating pulse oximetry capabilitiesanywhere along the length of the catheter, but ideally the sensor orsensors will be contained within the tubing of the device to ensureapproximation to the urethral mucosa. With this invention, thehealthcare provider will be able to decompress the bladder with aurinary catheter and obtain pulse oximetry data in a repeatable andaccurate manner. The power source for this device may be incorporatedwithin the urinary drainage bag or within the catheter itself Ideally,the pulse oximeter will be reusable and the catheter interface will bedisposable wherein the pulse oximeter is simply reversibly attached tothe disposable catheter and removed once measurements of oxygen are nolonger desired. The urinary catheter, then, may contain an opticallytransparent, or sufficiently transparent, channel for the oximetrysignal, ie a fiber-optic cable, transparent window, etc., and aninterface for the reusable oximeter and otherwise be a standard urinarycatheter. This method and device for urethral pulse oximetry may be usedin conjunction with any of the other embodiments detailed herein or maybe a stand-alone device in and of itself.

Detailed Description of the Preferred Embodiments

-   I. Device: Automated Urine Output Measurement-   II. Indications for Use (IFU): Any condition requiring urine output    monitoring-   III. Preferred Methods for Use:    -   a. Upon placement of a Foley catheter, ideally with a        temperature sensor or intra-vesicular sensor/probe, the        receptacle component of the Automated Urine Output Measurement        system is attached to the output tubing    -   b. The receptacle is attached to a stationary object, or the        patient themselves and the data ID for the receptacle is entered        into the RFID reader, which may be centralized and capable of        querying all Automated Urine Output Measurement receptacles        within a predefined range or area    -   c. The RFID reader then queries, and optionally powers, the RFID        chip within the receptacle which reports the fluid level based        on the impedance, conductance or other electrical properties of        sensors within the bag    -   d. This data is transmitted to centralized data collection point        where it may be monitored by an individual    -   e. If certain thresholds are not met, ie 30 cc/hr urine output,        local alarms (ie a beeping) or remote alarms (ie an alert at the        centralized monitoring station) may be triggered    -   f. The information obtained from the receptacle may be used in a        feedback loop to automate the delivery and/or extraction of        fluids and/or medicines from the patient to optimize therapy    -   g. In conjunction with urine output measurement the healthcare        professional may also attach an oximeter to a specifically        designed site on the urinary catheter in order to obtain pulse        oximetry measurements    -   h. Once the measurements have been completed, the oximeter may        be reused (or disposed of) and the urinary catheter either        removed or kept in place

1.-8. (canceled)
 9. An apparatus for automated, real-time measurement ofurine output, comprising: a catheter configured for insertion into abladder of a patient; an output receptacle in fluid communication withthe catheter for collecting urine from the bladder of the patient; atleast one sensor in communication with the output receptacle, whereinthe at least one sensor is configured to detect one or more biologicalparameters of urine collected within the output receptacle; and acontroller in communication with the at least one sensor, wherein thecontroller is programmed to automatically transmit data relating to theone or more biological parameters of the urine collected within theoutput receptacle to a remote data collection server.
 10. The apparatusof claim 9 wherein the at least one sensor comprises a temperaturesensor for sensing a temperature of the patient.
 11. The apparatus ofclaim 9 wherein the at least one sensor comprises an EKG sensor forsensing an EKG of the patient.
 12. The apparatus of claim 9 wherein theat least one sensor comprises a heart sensor for sensing a heart rate ofthe patient.
 13. The apparatus of claim 9 wherein the at least onesensor is configured to detect for a presence of blood, bacteria,protein, or hemoglobin in the urine collected within the outputreceptacle.
 14. The apparatus of claim 13 wherein the at least onesensor comprises an optical sensor.
 15. The apparatus of claim 9 whereinthe at least one sensor comprises a mechanical sensor.
 16. The apparatusof claim 9 wherein the output receptacle comprises an optically clearwindow.
 17. The apparatus of claim 9 wherein the data is associated witha particular individual patient.
 18. The apparatus of claim 9 whereinthe data is encrypted.
 19. A method of automating real-time measurementof urine output, comprising: receiving urine via a catheter from abladder of a patient into an output receptacle; detecting for one ormore biological parameters of the urine collected within the outputreceptacle via at least one sensor in communication with the outputreceptacle; processing the one or more biological parameters via acontroller in communication with the at least one sensor; andtransmitting data relating to one or more biological parameters of theurine to a remote data collection server.
 20. The method of claim 19wherein detecting further comprises detecting a temperature of thepatient.
 21. The method of claim 19 wherein detecting further comprisessensing an EKG of the patient.
 22. The method of claim 19 whereindetecting further comprises sensing a heart rate of the patient.
 23. Themethod of claim 19 wherein detecting further comprises detecting for apresence of blood, bacteria, protein, or hemoglobin in the urinecollected within the output receptacle.
 24. The method of claim 23wherein detecting comprises detecting for the presence via an opticalsensor.
 25. The method of claim 19 wherein transmitting furthercomprises associating the data with a particular individual patient. 26.The method of claim 19 wherein transmitting further comprises encryptingthe data prior to transmitting.